Full Press Release Details
TONIX PHARMACEUTICALS HOLDING CORP. 8-K
Tonix Pharmaceuticals
Announces Presentation on TNX-801 Vaccine Protection Against Monkeypox at the 4th Symposium of the Canadian Society for Virology
Poster Presentation Includes Preclinical
Data from Tonix's Program to Develop a Vaccine for Monkeypox and Smallpox
CHATHAM, N.J., June 8, 2022 (GLOBE NEWSWIRE) --
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced
that Ryan Noyce, Ph.D.,and David Evans, Professor, Department of Cell Biology, University of Alberta, together with scientists from Tonix
presented data from a research collaboration between Tonix Pharmaceuticals and The University of Alberta in a poster presentation at
the 4th Symposium of the Canadian Society for Virology held in Edmonton, Alberta, Canada on June 5, 2022. Copies of the poster are available
on the Tonix Pharmaceuticals corporate website at www.tonixpharma.com.
The poster titled, "Synthetic Chimeric Horsepox
Virus (scHPXV) Vaccination Protects Macaques from Monkeypox," describes data from animals vaccinated with TNX-8011
to protect against monkeypox. The poster presentation reports that all animals (eight of eight) vaccinated with TNX-801 were fully protected
with sterilizing immunity from a challenge with intra-tracheal monkeypox. The vaccinations with TNX-801 were well tolerated. Synthetic
horsepox virus is the basis for the Company's TNX-801 vaccine in development to protect against monkeypox and smallpox and for the
Company's Recombinant Pox Virus (RPV) platform to protect against other pathogens, including SARS-CoV-2.
"Our research work, in collaboration with Dr.
Noyce and Professor Evans at The University of Alberta, shows that vaccination with TNX-801 has the ability to protect against monkeypox
infection," said Seth Lederman, M.D., President and Chief Executive Officer. "Monkeypox infection of humans was rare during
the time people were vaccinated to protect against smallpox. After the eradication of smallpox, vaccination with live-virus vaccinia was
stopped in most of the world. Monkeypox cases have been rising in Africa for several years. Very recently a strain of monkeypox from West
Africa has caused clusters of monkeypox cases in many countries outside of Africa. We believe that vaccination with live-virus vaccines
like TNX-801 has the potential to control monkeypox again."
About TNX-801, TNX-1840 and TNX-1850
TNX-801 is a live virus vaccine based on synthesized
horsepox2,3. Tonix is developing TNX-801 for percutaneous administration as a vaccine to protect against monkeypox and smallpox.
Tonix has previously reported positive data from a monkeypox challenge study in non-human primates4. Tonix is also developing
TNX-1840 and TNX-1850 (horsepox-based live virus vaccines) for the prevention of COVID-19. TNX-1840 and TNX-1850 are designed to express
the spike protein from the omicron and BA.2 variants of SARS-CoV-2, respectively. Tonix has previously reported positive data from a SARS-CoV-2
challenge study in non-human primates in which animals were vaccinated with TNX-1800, a horsepox-based vaccine expressing spike protein
from the Wuhan strain5. Tonix's TNX-801 was synthesized2 based on the sequence of the 1976 natural isolate
Mongolian horsepox clone MNR-763. Molecular analysis of DNA sequences suggests that TNX-801 is closer than modern smallpox vaccines to
the vaccine discovered and disseminated by Dr. Edward Jenner in 17986-8. For example, recent studies9,10 have shown
approximately 99.7% colinear identity between TNX-801 and the circa 1860 U.S. smallpox vaccine VK05.11 The small
plaque size in culture of TNX-801 appears
identical to the U.S. Centers for Disease Control publication of the natural isolate12. Relative to vaccinia, horsepox has
substantially decreased virulence in mice2. Dr. Edward Jenner invented vaccination in 1798 and the procedure was called "vaccination"
because cow' is vacca' in Latin and the inoculum material was initially obtained from lesions on the udders
of cows affected by a mild disease known as cowpox. However, Dr. Jenner suspected that cowpox originated from horses.8 Subsequently, Dr.
Jenner and others immunized against smallpox using material directly obtained from horses. The use of vaccines from horses was sometimes
called equination' from the Latin equus' which means horse'13. Equination and vaccination
were practiced side-by-side in Europe13,14.
About the Recombinant Pox Virus (RPV) Platform
Horsepox virus and vaccines based on its use
as a vector are live replicating viruses that elicit strong immune responses. Live replicating orthopoxviruses, like vaccinia or horsepox,
can be engineered to express foreign genes and have been exploited as platforms for vaccine development because they possess; (1) large
packaging capacity for exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence
or genomic integration in the host, (4) strong immunogenicity as a vaccine, (5) ability to rapidly generate vector/insert constructs,
(6) manufacturable at scale, and (7) ability to provide direct antigen presentation. Relative to vaccinia, horsepox has substantially
decreased virulence in mice2. Horsepox-based vaccines are designed to be single dose, vial-sparing vaccines, that can be manufactured
using conventional cell culture systems, with the potential for mass scale production and packaging in multi-dose vials. Tonix's
TNX-801 and RPV vaccine candidates are administered percutaneously using a two-pronged, or "bifurcated" needle. The major
cutaneous reaction or "take" to vaccinia vaccine was described by Dr. Edward Jenner in 1796 and has been used since then as
a biomarker for protective immunity to smallpox, including in the World Health Organization's (WHO) accelerated smallpox eradication
program that successfully eradicated smallpox in the 1960's. The "take" is a measure of functional T cell immunity validated
by the eradication of smallpox, a respiratory-transmitted disease caused by variola.
About Monkeypox and Smallpox
Monkeypox15 and smallpox16
are diseases in humans called by the monkeypox and smallpox (or variola) viruses, respectively. Monkeypox and variola are closely related
orthopox viruses. Vaccination against smallpox with live virus vaccines based on horsepox or vaccinia protects against monkeypox. After
routine smallpox vaccination was stopped in about 1970, monkeypox has become a growing problem in Africa. Recently approximately 300 cases
have been identified outside of Africa.17 Smallpox is considered eradicated, but there are concerns about malicious reintroduction.
About Tonix Pharmaceuticals Holding Corp.1
Tonix is a clinical-stage
biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease
and alleviate suffering. Tonix's portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious
CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's
lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia
with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the first quarter of 2023. TNX-102 SL is
also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID
in the second quarter of 2022. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication that is expected
to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA. Finally,
TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with
a Phase 2 study in the second half of 2022. Tonix's rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin)
for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix's immunology portfolio
includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500 which is a humanized
monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment
of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix's infectious disease
pipeline consists of a vaccine in development to prevent smallpox and monkeypox called TNX-801, next-generation vaccines to prevent COVID-19,
and a platform to make fully human monoclonal antibodies to treat COVID-19. Tonix's lead vaccine candidates for COVID-19 are TNX-1840
and TNX-1850, which are live virus vaccines based on Tonix's recombinant pox live virus vector vaccine platform.
product candidates are investigational new drugs or biologics and have not been approved for any indication.
2Noyce RS, et al. (2018)
PLoS One. 13(1):e0188453
(2006) J Virol. 80(18):9244-58.PMID:16940536
Synthetic Chimeric Horsepox Virus (scHPXV) Vaccination Protects Macaques from Monkeypox* Presented as a poster at the American Society
of Microbiology BioThreats Conference - January 29, 2020, Arlington, VA. (https://content.equisolve.net/tonixpharma/media/10929ac27f4fb5f5204f5cf41d59a121.pdf)
5Tonix Press Release
Engl J Med. (2017) 377:1491.
7Qin et al. J. Virol.
Inquiry Into the Causes and Effects of the Variolae Vaccinae: A Disease Discovered in Some of the Western Counties of England, Particularly
Gloucestershire, and Known by the Name of the Cow Pox." London: Sampson Low, 1798.
9Brinkmann A et al, Genome
Biology (2020) 21:286 https://doi.org/10.1186/s13059-020-02202-0
10Duggan A et al. Genome
Biology (2020) 21:175 https://doi.org/10.1186/s13059-020-02079-z
11Tonix press release.